Job Details
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Job Id 923323
Title Regulatory Associate - Diagnostics
Job Type Permanent
City Hyderabad
State Telangana
Zip
Job Description

MakroCare is an Expert Strategic Development and Commercialization Global Partner for Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region Expansion

Regulatory Associate - Diagnostics
• Good knowledge of medical terminology and ICH GCP guidelines.
• Good knowledge of MD regulations/ guidanecs, latest updates.
• ISO 10993 Standards knowledge
• Analyze the Material characterization & bio-compatibility reports
• Ability to understand the purpose and requirements of the assigned project and delivering consistently high quality regulatory documents that meet project requirements.  
• Analyze & interprete medical/scientific data
• Authoring and reviewing technical files like Biocompatibility reports as per defined templates
• Liaising with medical, biomedical enginnering, scientific and clinical staff
 • Good Communication skills, Listening skills, Problem-solving skills
 • Good knowledge on usage of MS Office in reporting

MakroCare | A MakroGroup Company | www.MakroCare.com

MakroCare is an Expert Strategic Development and Commercialization Global Partner for Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region Expansion.
MakroCare is Certified ISO 9001 (QMS), ISO 27001 (ISMS), ISO 20000 (ITSM), ISO 14155 (Medical Device Clinical Investigations)

MakroCare Awarded as:
•             Best Biopharmaceutical Regulatory Consultancy Firm – Global Health & Pharma
•             Best Pharmaceutical Strategic Development Specialist - UK Enterprises
•             The Outstanding Consulting Firm - Insights Success
•             AI Excellence in Regulatory & Automation Solutions - Acquisition International
•             AI Excellence in Best Bio Pharma Development Partner - Acquisition International
•             Best Practices Award - Clinical Informatics
•             NJ Excellence Award - US Institute for Excellence in Commerce
•             Best Biotech Award - US Commerce Association
•             Clinical Research Team and Best Technological Development in Clinical Trials Finalists - Scrip Awards
•             Circle Of Excellence – MerchantCircle

About MakroGroup | www.MakroGrp.com

Makro Group of Organizations established in 1996, Makro provides a complete range of solutions for every stage of business and information lifecycle.

•             MakroCare, DDi, MakroTech and MakroScientific are MakroGroup Companies
•             DDi Awarded by Insights Success, CIO, Corporate LiveWire, Pharma Tech Outlook, Clinical Informatics & SCRIP
•             MakroTech is Awarded 3-time FAST 500 (Deloitte), 3-time INC 5000 company & TOP 100 diversity business in NJ
•             MakroFoundation is a Suicide Prevention Helpdesk, part of Makro CSR Initiative, has counseled over 3000 people.


Qualification
Experience 0-3 Years
Job Category Regulatory
Posted On 11/23/2020
Expires On 12/23/2020
 
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